Precision Medicine Group’s Post

Precision's Anshul Mangal weighs in on what to expect in 2024 regarding biopharma manufacturing and supply-related issues in this Scrip Asks Part 3 series. "Cell and gene therapies will continue to dominate the innovative clinical pipeline with the largest number of treatments in clinical trials (589 gene therapies and 568 cell therapies). The recent historic landmark of the first CRISPR technology gaining regulatory approval signals confidence in this approach. Additionally, as the adoption of radioligand therapy increases, it continues to show profound potential. One of the most promising aspects of radioligand therapy lies in the potential to create unique combinations of radioactive atoms and targeting molecules tailored to specific tumor types." Read the article here (subscription required): https://hubs.ly/Q02jhS1j0 #precisionmedicine #biopharma #clinicaltrials

Precision's Anshul Mangal weighs in on what to expect in 2024 regarding biopharma manufacturing and supply-related issues in this Scrip Asks Part 3 series. "Cell and gene therapies will continue to dominate the innovative clinical pipeline with the largest number of treatments in clinical trials (589 gene therapies and 568 cell therapies). The recent historic landmark of the first CRISPR technology gaining regulatory approval signals confidence in this approach. Additionally, as the adoption of radioligand therapy increases, it continues to show profound potential. One of the most promising aspects of radioligand therapy lies in the potential to create unique combinations of radioactive atoms and targeting molecules tailored to specific tumor types." Read the article here (subscription required): https://hubs.ly/Q02jhKP30 #precisionmedicine #biopharma #clinicaltrials

It may be February, but I am still pondering what 2024 holds 💡 . My colleague, Dr. George Buchman, shares his insights on the future of manufacturing and supply in the cell & gene therapy industry with Scrip: “The impressive steps forward in cell and gene therapy over the past few years give cause for great optimism. We expect several trends to accelerate, including the expansion of these therapies into broader indications. There are thousands of diseases affecting millions of people that could one day have a one-time, even curative, treatment option.  Broad access to these medicines hinges on continued advances in enabling technologies that improve capabilities, expand applicability and lower manufacturing costs. In 2024 and beyond, we expect to see therapeutic viral vectors improve on all three fronts. The field is focused on improving vector capsids, for improved tissue targeting and to modulate immunogenicity, enabling potential re-dosing using the same vector serotype.  At the same time, we expect to see continued benefit from platform approaches for viral vector process development, production and analytics, driving rapid delivery to first-in-human studies, and streamlining the path to commercial.” https://lnkd.in/gXnZmxcu

Advance Your Cell and Gene Therapy Projects! We're excited to share our latest white paper: "Optimizing End-to-End Contract Analytical Support for Cell and Gene Therapies." Dive into this valuable guide to see how Alcami can bolster your CGT drug development through our extensive offerings, including: • Quality Control and Analytical Strategy Formulation: Customized approaches to guarantee quality and adherence at each phase. • Methodology Development, Qualification, and Validation: Dependable methods for precise and consistent analytical outcomes. • GMP Cold and Cryogenic Storage Solutions: Reliable storage options that safeguard your substances across the distribution network. • Fill-Finish Services for DNA, RNA, and Additional Raw Materials: Skilled management to preserve the integrity of your essential elements. At Alcami, we're committed to aiding your progress in creating groundbreaking therapies. Get the white paper now and learn how we can collaborate towards your achievement!** 👉 https://gag.gl/tdwE1C #CellTherapy #GeneTherapy #Pharmaceuticals #Biotechnology #DrugDevelopment #Alcami

Cell and gene therapies are quickly advancing, and many new products are in clinical development. Bioanalytical testing, such as PCR-based methods, are crucial for ensuring the safety and efficacy of these drugs. However, there's no established regulatory guidance for validating PCR assays in this context. This white paper explores validation criteria, comparing them to assess potential risks in PCR validation parameters. » https://bit.ly/46IyU6V #cellandgenetherapies #CGT #clinicaldevelopment #bioanalytical

With 27 FDA-approved cell and #genetherapy products to date, #plasmidDNA (pDNA) continues to play a crucial function within advanced therapies medicinal product (ATMP) development. In this webinar, Andrew Frazer (Associate Director, Scientific Solutions, Gene Therapy CDMO Services, Charles River Laboratories) will explore common manufacturing and quality standards for pDNA and how they align with regulatory guidance. Watch this #webinar to learn about: • Manufacturing strategies and mitigation plans to streamline #ATMP program • The role of #pDNA as a critical starting material • Case studies demonstrating expedited development and manufacture of advanced therapies Watch this webinar at you convenience below:

Mark your calendar for an insightful panel discussion with Dr. Rachel Legmann, Sr. Director of Technology, Gene Therapy at Repligen, and a lineup of industry experts. The discussion, titled “Phase-Appropriate Manufacturing: Trial and Error… or Trial and Triumph?”, will take place on September 24th at 4:30 PM during BPI Boston. Don’t miss this opportunity to hear from the experts about the key challenges facing manufacturing in the emerging cell and gene therapy industry Topics: - Navigating the complex grey area of manufacturing for Phase 1 and 2 trials - Keeping efficiency while complying with limited guidance - Need conversation between regulators and developers - Lessons learnt and case studies from companies moving between clinical phases - Therapeutic Developer/CDMO dynamics in the phase 1 and beyond - How to best leverage CDMO expertise and capital efficiency Join the discussion! https://lnkd.in/gt2mFKGN #BPIconf #bioprocessing #genetherapy #processdevelopment #repligen #monoclonalantibodies #vaccines

As tragic as the COVID-19 pandemic was, one silver lining is that government agencies across the world realized “what they do is more common than divergent.” This is a quote from Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, and something I agree with as well. This realization is already profoundly benefitting cell and gene therapy development and commercialization efforts. As one example, leading regulators across the globe created the Collaboration on Gene Therapies Global Pilot to improve efficiencies in clinical reviews and lower the cost of bringing these therapies to market. https://lnkd.in/g2bK7hZq

Last week was thrilling as we participated in two key industry events 🚀 —the North Carolina Regulatory Affairs Forum (NCRAF) and the Biomanufacturing and Process Development (BPD) Cell and Gene Therapy Symposium. These events highlight our dedication to leading innovation and regulatory standards in the Life Sciences industry. We are aware of the marked differences between Cell & Gene Therapy (CGT) and Biopharmaceutical BLA submissions and our services are tailored to help both startups and global companies get their products to market faster with guaranteed potency and lifesaving results. #LifeSciences #RegulatoryAffairs #Biomanufacturing #GeneTherapy #NCRAF #BPDSymposium

#Patients that rely on innovative #cellandgenetherapies are often extremely ill and need to recieve treatment as soon as possible ⏳. All cell and gene therapy products require the full range of safety, environmental, and cellular attribute quality tests, however, the testing process can be time-consuming and complex. It is extremely important to increase both speed and the ease of testing when it comes to cell and gene therapies. ➡️ In our latest blog article, Félix A MONTERO-JULIAN PhD and Thomas Jones discuss how the continued evolution of rapid testing and analytical methods are critical to the availability of these much-needed therapies: https://lnkd.in/dmR66QU5